Study on Construction of Whole Lifecycle Cohort, Big Data Management and Clinical Prognosis of Cardio-Renal-Metabolic (CKM) Syndrome (CKM-LCBP)

April 19, 2026 updated by: Dajun Chai, First Affiliated Hospital of Fujian Medical University
This is a single-center observational registry study aiming to establish a structured clinical and multimodal imaging database for cardiovascular-kidney-metabolic (CKM) populations and to support lifecycle follow-up and outcome management. Adult patients aged 18-80 years with cardiovascular, kidney, and/or metabolic diseases or key data for CKM phenotyping will be enrolled at the First Affiliated Hospital of Fujian Medical University. The study integrates retrospective data entry and prospective follow-up, including clinical records, laboratory tests, medications, electrocardiography, echocardiography, vascular function assessment, carotid and abdominal ultrasound, bone density, coronary CTA and post-processing data. The primary outcome is the first occurrence of a cardiorenal composite endpoint. Participants will be followed for up to 5 years through active annual follow-up and passive monthly data updates to support risk stratification, real-world evidence generation, and CKM management pathway optimization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a single-center CKM patient registry with retrospective data entry and prospective lifecycle follow-up. A patient-centered master index will be established primarily on the basis of hospitalization identifiers to integrate multi-source hospital data, including discharge records, diagnoses, laboratory testing, medications, electrocardiography, echocardiography, baPWV/ABI, carotid ultrasound, abdominal ultrasound, bone density, coronary CTA and post-processing metrics, and clinical outcome events. A structured longitudinal database will be created to support standardized phenotyping, event adjudication, and repeat-assessment tracking. The primary objective is to build a dynamic registry platform for CKM-related inpatients and to support long-term follow-up, outcome surveillance, risk stratification, and real-world evidence generation. The study is planned for 5 years, from March 1, 2026 to February 28, 2031, with annual active follow-up and monthly passive data updates. Major outcomes include a time-to-first cardiorenal composite endpoint, all-cause mortality, 3-point major adverse cardiovascular events, heart failure hospitalization or cardiovascular death, and additional pre-specified cardiovascular, renal, metabolic, oncologic, cognitive, and imaging progression outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital-based adult CKM-related inpatients at the First Affiliated Hospital of Fujian Medical University with available clinical and multimodal examination data for longitudinal registry follow-up.

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Inpatient record available at the First Affiliated Hospital of Fujian Medical University with retrievable identifiers for data linkage.
  • Cardiovascular disease, kidney disease, metabolic disease, or key examination/laboratory information supporting CKM phenotyping.
  • Willingness to participate and provision of written informed consent.
  • Ability to complete baseline assessment and follow-up.
  • Full civil capacity and ability to understand study information.

Exclusion Criteria:

  • Refusal to provide written informed consent.
  • Severe psychiatric disease or cognitive impairment precluding participation.
  • End-stage disease with expected survival less than 1 year.
  • Long-term absence more than 6 months preventing reliable follow-up.
  • Participation in another clinical study that may interfere with endpoint adjudication.
  • Missing key fields preventing linkage of examinations, imaging, and outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
CKM Registry Cohort
Adults aged 18 to 80 years receiving inpatient care at the First Affiliated Hospital of Fujian Medical University with cardiovascular disease, kidney disease, metabolic disease, or key examination and laboratory data supporting CKM phenotyping, enrolled for structured data collection and longitudinal follow-up.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First occurrence of a cardiorenal composite endpoint
Time Frame: Up to 5 years from enrollment
Time to first occurrence of cardiovascular death or kidney disease progression, defined as sustained decline in eGFR of at least 40% from baseline, sustained eGFR below 15 mL/min/1.73 m², initiation of maintenance dialysis, kidney transplantation, or renal death.
Up to 5 years from enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Up to 5 years from enrollment
Time to death from any cause during follow-up.
Up to 5 years from enrollment
3-point major adverse cardiovascular events (3-point MACE)
Time Frame: Up to 5 years from enrollment
Time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke.
Up to 5 years from enrollment
First hospitalization for heart failure or cardiovascular death
Time Frame: Up to 5 years from enrollment.
Time to first hospitalization for heart failure or cardiovascular death during follow-up.
Up to 5 years from enrollment.
Nonfatal Myocardial Infarction
Time Frame: Up to 5 years from enrollment
First occurrence of nonfatal myocardial infarction during follow-up.
Up to 5 years from enrollment
Nonfatal Ischemic Stroke
Time Frame: Up to 5 years from enrollment
First occurrence of nonfatal ischemic stroke during follow-up.
Up to 5 years from enrollment
Incident Atrial Fibrillation
Time Frame: Up to 5 years from enrollment
New-onset atrial fibrillation among participants without a history of atrial fibrillation at baseline, confirmed by 12-lead electrocardiography, Holter monitoring, or inpatient/outpatient clinical diagnosis during follow-up.
Up to 5 years from enrollment
Coronary Revascularization
Time Frame: Up to 5 years from enrollment
First occurrence of coronary revascularization, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), during follow-up.
Up to 5 years from enrollment
Aortic Disease Intervention
Time Frame: Up to 5 years from enrollment
First occurrence of endovascular or surgical intervention for aortic dissection, aortic aneurysm, penetrating aortic ulcer, or other aortic diseases during follow-up.
Up to 5 years from enrollment
Peripheral Vascular Events
Time Frame: From enrollment until the date of first documented peripheral vascular event, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.
First occurrence of peripheral vascular events, including acute limb ischemia, peripheral arterial revascularization, or major amputation due to vascular causes.
From enrollment until the date of first documented peripheral vascular event, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.
Incident Diabetes Mellitus
Time Frame: Up to 5 years from enrollment
New-onset diabetes mellitus among participants without diabetes at baseline, defined as a new clinical diagnosis of diabetes, initiation of glucose-lowering therapy, or laboratory evidence meeting diagnostic criteria during follow-up.
Up to 5 years from enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incident Malignant Tumor
Time Frame: Up to 5 years from enrollment
First occurrence of a newly diagnosed malignant tumor during follow-up.
Up to 5 years from enrollment
Incident Dementia Based on Clinical Diagnosis Records
Time Frame: From enrollment until the date of first documented incident dementia, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.
First occurrence of newly diagnosed dementia identified from inpatient or outpatient diagnosis records, discharge records, or follow-up verification during longitudinal follow-up.
From enrollment until the date of first documented incident dementia, death, loss to follow-up, or end of study, whichever came first, assessed up to 5 years.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score
Time Frame: Baseline and annual follow-up assessments through longitudinal follow-up, assessed up to 5 years.
Cognitive decline assessed by change from baseline in Montreal Cognitive Assessment (MoCA) total score during longitudinal follow-up; lower scores indicate worse cognitive performance.
Baseline and annual follow-up assessments through longitudinal follow-up, assessed up to 5 years.
Coronary CTA Imaging Progression
Time Frame: Up to 5 years from enrollment
Longitudinal progression of coronary computed tomography angiography findings, including stenosis severity, plaque burden, plaque composition, coronary artery calcium score, CT-QFR, epicardial adipose tissue parameters, and perivascular fat parameters.
Up to 5 years from enrollment
Progression of MASLD/Fatty Liver-Related Imaging Phenotypes
Time Frame: Up to 5 years from enrollment
Longitudinal progression of metabolic dysfunction-associated steatotic liver disease (MASLD) or fatty liver-related imaging phenotypes during follow-up.
Up to 5 years from enrollment
Change From Baseline in Mean Carotid Intima-Media Thickness (CIMT)
Time Frame: Baseline and repeat carotid ultrasound assessments during longitudinal follow-up, assessed up to 5 years.
Longitudinal change from baseline in mean carotid intima-media thickness measured by carotid ultrasound during follow-up.
Baseline and repeat carotid ultrasound assessments during longitudinal follow-up, assessed up to 5 years.
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years.
Longitudinal change from baseline in left ventricular ejection fraction measured by echocardiography during follow-up.
Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years.
Change From Baseline in Left Ventricular Mass Index (LVMI)
Time Frame: Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years.
Longitudinal change from baseline in left ventricular mass index measured by echocardiography during follow-up.
Baseline and repeat echocardiographic assessments during longitudinal follow-up, assessed up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Fujian Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dajun Chai, First Affiliated Hospital of Fujian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRCTA,ECFAH of FMU[2026]046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified individual participant data may be considered for sharing subject to institutional approval, data security requirements, ethics approval where applicable, and the minimum necessary principle. A formal data-sharing policy has not yet been finalized at the time of registration.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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